Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT02256332
Eligibility Criteria:
Inclusion Criteria:
* Male and female volunteers with confirmed Type II diabetes not treated with pharmaceutical-based glucose lowering treatment for past three months (controlled solely through diet and exercise);
* Age ≥ 20 and ≤ 65 year at screening;
* Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;
* HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). At discretion of the study physician, subjects with HbA1c \>53 mmol/mol and \<58 mmol/mol (\>7.0% and \< 7.5%) controlled solely through diet and exercise are also allowed to participate.
Exclusion Criteria:
* Being an employee of Unilever or research site;
* Chronic smokers, tobacco chewers and drinkers;
* No medication, including vitamins and tonics, except for cholesterol, as determined by the physician;
* Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;
* Allergy to any food or cosmetics;
* If female, not being pregnant or planning pregnancy during the study period;
* If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT02256332
Study Brief:
Protocol Section:
NCT02256332